Medical Device Design and Regulation

  1. Materials and Biocompatibility
    1. Common Medical Device Materials
      1. Metals
        1. Stainless Steel
          1. Titanium
            1. Cobalt-Chrome Alloys
            2. Polymers
              1. PEEK
                1. Polyethylene
                  1. Silicone
                  2. Ceramics
                    1. Alumina
                      1. Zirconia
                      2. Biologics and Combination Products
                        1. Tissue-Derived Materials
                          1. Drug-Device Combinations
                        2. Biocompatibility Testing
                          1. Definition and Importance
                            1. Cytotoxicity
                              1. Sensitization and Irritation
                                1. Systemic Toxicity
                                  1. Hemocompatibility
                                    1. Implantation Effects
                                      1. Genotoxicity and Carcinogenicity
                                        1. Degradation Products
                                        2. Sterilization and Material Compatibility
                                          1. Ethylene Oxide
                                            1. Gamma Irradiation
                                              1. Steam Sterilization
                                                1. Electron Beam
                                                  1. Impact of Sterilization on Material Properties
                                                    1. Packaging Considerations

                                                  Previous

                                                  7. Risk Management

                                                  Go to top

                                                  Next

                                                  9. Pre-Clinical Testing